MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FLUID DELIVERY LINES

Catalog Number	734-07
Medical Device Problem Codes	Nonstandard Device (1420); Use of Device Problem (1670); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the arctic sun device gave an alarm related to an open line.Per additional information updated from ttm on 16jan2026, biomed trying to perform maintenance on device.Had bypass loops in place and keeps getting message that there was air in the lines.Per review of wo notes the device was not configured correctly for testing, they were using a simulator to test with pads connected.During functional testing with ts the device displayed alarm 41.It was then determined that the device had a failed flow meter.Circulation pump command (cpc) was 49%, inlet pressure (ip) was -7.0, flow rate (fr) was 0.0.Shunt connected and verified visual flow.
Additional Manufacturer Narrative
This event was confirmed use related, not attributed to a device malfunction.Submitting the investigation details as additional information.The initial reporter's zip code: (b)(6).The reported issue was confirmed.The root cause for the reported event is the device being incorrectly configured for testing.Per additional information updated from ttm on 16jan2026, biomed trying to perform maintenance on device.Had bypass loops in place and keeps getting message that there was air in the lines.Per review of wo notes the device was not configured correctly for testing, they were using a simulator to test with pads connected.The complaint or reported issue was confirmed through other elements of the investigation to not be manufacturing related.The instructions for use are found to be adequate.The ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.Service: contact medivance customer support for technical support and customer service instructions to enable appropriately qualified technical personnel to repair those parts of the equipment that medivance considers repairable.Calibration: 7.3.6 low flow alarm: if the device shows a low flow alarm, perform the following steps: power device on; ensure fluid delivery line is connected.With no pads or shunt tube attached, start the device in manual control and allow 3 minutes for bypass flow to stabilize.Using the diagnostic screen, verify a flow rate of > 1.5 lpm and a circulation pump command of less than 70 percent.If this cannot be achieved it indicates an air leak either internal to the device or in the fluid delivery line.To confirm there is no internal air leak, remove fluid delivery line and place thumb over the left port.Repeat the test in step 3.To confirm there are no leaks in the fluid delivery line valves, attach a shunt tube to any set of valves and initiate manual control.Watch for water to flow through tube, then without stopping, move shunt tube quickly to the opposite branch of the fluid delivery line.Watch for water flow through the tube.Place the fluid delivery line on the floor.Press stop.Remove the shunt tube.Monitor the fluid delivery line valves for any water leaks over the next 5 minutes.To confirm the pad connector seals are not damaged, inspect the orange seal at the end of each valve and look for damage.Actuate each valve and ensure it moves freely.Based on the results of the investigation, no additional actions are needed.Corrections: d, e, f, h.Udi format updated with available product information per gudid.H11: sections a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the arctic sun device gave an alarm related to an open line.Per additional information updated from ttm on 16jan2026, biomed trying to perform maintenance on device.Had bypass loops in place and keeps getting message that there was air in the lines.Per review of wo notes the device was not configured correctly for testing, they were using a simulator to test with pads connected.During functional testing with ts the device displayed alarm 41.It was then determined that the device had a failed flow meter.Circulation pump command (cpc) was 49 percent, inlet pressure (ip) was -7.0, flow rate (fr) was 0.0.Shunt connected and verified visual flow.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, FLUID DELIVERY LINES
• Common Device Name: TEMPERATURE MANAGEMENT SYSTEM
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 24206099
• Report Number: 1018233-2026-00440
• Device Sequence Number: 14810362
• Product Code: DWJ
• UDI-Device Identifier: 00801741080265
• UDI-Public: (01)00801741080265
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 734-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 02/19/2026; 05/04/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/27/2026; 05/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown